Resp-O2

GUDID 00840117305663

Resp-O2 Heat Moisture Exchanger and B/V Filter (HMEF) 1000, CO2 Port, Adult

DYNAREX CORPORATION

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID00840117305663
NIH Device Record Keyb23b0188-4b14-4385-9a14-9fb5af6050e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameResp-O2
Version Model Number30100
Company DUNS008124539
Company NameDYNAREX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840117305656 [Primary]
GS100840117305663 [Package]
Contains: 00840117305656
Package: Case [50 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-30
Device Publish Date2021-04-22

Devices Manufactured by DYNAREX CORPORATION

00810180841689 - LabChoice Specimen Bags, Clear, 8" x 10", 1.8 MIL2025-04-15 Non-Sterile
00810180841672 - LabChoice Specimen Bags with Pouch, 4" x 6", 1.8 MIL 2025-04-15 Non-Sterile
00810180841702 - DispoSafety Medical Waste Biohazard Bags, 24" x 25.6", 1.18 MIL, 12 Gallon2025-04-15
00810180841719 - DispoSafety Medical Waste Biohazard Bags, 36" x 30", 1.2 MIL, 30 Gallon2025-04-15
00810180841696 - DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL 2025-04-15
00840117340718 - Biopsy Punch, Sterile, 3.0 mm Grey2025-04-08 STERILE-R
00840117340725 - Biopsy Punches, Sterile, 3.5 mm, Yellow2025-04-08 STERILE-R
00840117340732 - Biopsy Punches, Sterile, 4.0 mm, Blue2025-04-08 STERILE-R

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